UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004228 |
|---|---|
| Receipt number | R000005083 |
| Scientific Title | Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients |
| Date of disclosure of the study information | 2010/10/31 |
| Last modified on | 2012/03/17 10:19:44 |
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Basic information
Public title
Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients
Acronym
HT for swallowing reflex and prevention of pneumonia in brain disease
Scientific Title
Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients
Scientific Title:Acronym
HT for swallowing reflex and prevention of pneumonia in brain disease
Region
| Japan |
Condition
Condition
post cerebrovascular disease, neurodegenerative diseases e.g. PD, SCD, ALS
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of BHT for swallowing refles disorder and preventing aspiration pneumonia in brain disease patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
wallowing reflex, pneumonia onset
Key secondary outcomes
days with fever over 37.5, self-feeding
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Taking BHT (traditional Chinese medicine) 8weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.elderly patients with brain diseases
2.Swallowing reflex can be tested
3.Aspiration pneumonia history at least 1 time
4.Transaminases are less than twice of w.n.l.
5.Cre less than 2.0
6.Stable status and will survive more than 3 months after baseline
7.With informed concent and agreement from patients or family members
Key exclusion criteria
1.Patients having malignancy, severe heart diseases and other factors that would influence the results.
2.Chronic respiratory diseases e.g. BA, COPD
3.Without agreement of patients or family members
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Takemoto |
Organization
Tagami memorial hospital
Division name
Internal medicine
Zip code
Address
Nisibeppucho 1779, Kagoshima City
TEL
099-282-0051
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Takemoto |
Organization
Tagami memorial hospital
Division name
Internal medicine
Zip code
Address
Nisibeppucho 1779, Kagoshima City
TEL
099-282-0051
Homepage URL
yoshinobu_takemoto@shunpukai.com
Sponsor or person
Institute
Dept. of traditional Asian medicine, Postgraduate school of medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Yonezawa hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Tagami memorial Hospital, Kagoshima Prefacture, National Yonezawa hospital, Yamagata Pref
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://jglobal.jst.go.jp/public/20090422/201102220184329522
Number of participants that the trial has enrolled
Results
Hangekobokuto improved the swallowing refex and decrease the pneumonia onset.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 17 | Day |
Last modified on
| 2012 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005083
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
